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This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.
All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used.
The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block.
This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 1ml 0.9% NaCl) |
|
| Dexamethasone group | Experimental | Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 2mg dexamethasone) |
|
| Dexmedetomidine group | Experimental | Bilateral ESPB (2 x 20ml 0.2% ropivacaine with 25ug dexmedetomidine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9%NaCl | Drug | 2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total opioid Consuption | Cumulative opioid consumption during the first 24 and 48 hours after surgery, converted to morphine milligram equivalents (MME) | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS | Numerical Rating Scale (0 - no pain; 10 - the worst pain ever) | 4 hours after surgery |
| NRS | Numerical Rating Scale (0 - no pain; 10 - the worst pain ever) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malgorzata Reysner, M.D. Ph.D. | Contact | +48 61 873 83 03 | mreysner@ump.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Recruiting | Poznan | 62-701 | Poland |
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| Dexamethasone 4mg |
| Drug |
2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone |
|
| Dexmedetomidine | Drug | 2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine |
|
| 8 hours after surgery |
| NRS | Numerical Rating Scale (0 - no pain; 10 - the worst pain ever) | 12 hours after surgery |
| NRS | Numerical Rating Scale (0 - no pain; 10 - the worst pain ever) | 24 hours after surgery |
| NRS | Numerical Rating Scale (0 - no pain; 10 - the worst pain ever) | 48 hours after surgery |
| Nerve injury | Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome) | 12 hours after surgery |
| Nerve injury | Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome) | 24 hours after surgery |
| Nerve injury | Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome) | 48 hours after surgery |
| adverce effects | nausea, vomitting, bradycardia, hypotension | 48 hours after surgery |
| Time to first rescue analgesia | Time after surgery when the patient needs rescue analgesia for the first time | 48 hours after surgery |
| blood glucose | Blood glucose concentration measured postoperatively | 12 hours after surgery |
| blood glucose | Blood glucose concentration measured postoperatively | 24 hours after surgery |
| blood glucose | Blood glucose concentration measured postoperatively | 48 hours after surgery |
| NLR - Neutrophil-to-Lymphocyte Ratio | NLR will be calculated from complete blood count results | 12 hours after surgery |
| NLR - Neutrophil-to-Lymphocyte Ratio | NLR will be calculated from complete blood count results | 24 hours after surgery |
| NLR - Neutrophil-to-Lymphocyte Ratio | NLR will be calculated from complete blood count results | 48 hours after surgery |
| PLR - Platelet-to-Lymphocyte Ratio | PLR will be calculated from complete blood count results | 12 hours after surgery |
| PLR - Platelet-to-Lymphocyte Ratio | PLR will be calculated from complete blood count results | 24 hours after surgery |
| PLR - Platelet-to-Lymphocyte Ratio | PLR will be calculated from complete blood count results | 48 hours after surgery |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D003907 | Dexamethasone |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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